MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR PLUS CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 260P

Device Problem Degraded (1153)

Patient Problems Chest Pain (1776); Fibrosis (3167); Cough (4457); Pulmonary Hypertension (4460); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 12/21/2021

Event Type  Death  

Event Description

The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused idiopathic pulmonary fibrosis, pulmonary hypertension, cough, skin irritation, chest pressure and fluid build up which expidited the patient's death.The patient did not report to receive medical intervention.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported the voluntary medwatch number in the initial report in section g.2.The voluntary medwatch number is mw5105961.

• Brand Name: REMSTAR PLUS CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 14471379
• MDR Text Key: 292388858
• Report Number: 2518422-2022-25182
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959028647
• UDI-Public: 00606959028647
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 260P
• Device Catalogue Number: 260P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other